The HMV code is no guarantee of economic success, but hit open doors and often turns out to be necessity in order to play a role in the German market for medical technical aid.
Experienced applicants are very familiar with their own product segment and usually also know how an application at the National Association of Statutory Health Insurance Funds (GKV Spitzenverband, GKV) works. They are not surprised if, despite all their routine, they receive a request for official statement („Anhörungsschreiben“).
A letter in response to your HMV application
The request for official statement is about the fact that there are still open questions about the application process to be clarified and the GKV therefore asks for further information or documents before a decision is made. In terms of content, the letter of request for official statement can be about minor things such as missing information in the instructions for use or major issues such as missing or inadequate proof of medical benefit. Formally, a letter of request for official statement can be a challenge for the inexperienced, especially non-german speakers.
A possible scenario reading the first response to your application from the GKV
Before the actual deviations are briefly described, some rights and obligations are pointed out for formal reasons: “(…) im Sinne des § 3 Nr. 1 des Medizinproduktegesetzes gilt der Nachweis der Funktionstauglichkeit und der Sicherheit durch die CE-Kennzeichnung grundsätzlich als erbracht (vgl. § 139 Abs. 3 und 4 SGB V).”
“(…) within the meaning of § 3 No. 1 of the Medical Devices Act, the proof of functionality and safety by means of the CE marking is generally considered to have been provided (see § 139 Paragraph 3 and 4 SGB V).”
I beg your pardon? Do I meet this requirement or not? Something missing?
You will skip this part for the time being and you will be formally informed that you have submitted an application for inclusion in the HMV. In the following paragraphs you will also find the supposed deviations with the kind request “…to submit convincing documents.”„…aussagekräftige Unterlagen nachzureichen.“
It is clear that the person evaluating at the GKV cannot do the job of the applicants, but you as the applicant may probably ask yourself:
What are convinving documents? I submitted everything I have!
In the following paragraph you will find a very similar friendly prompt, and so on and so forth. Slowly the thought ist forming that it might be a bit more time-consuming to answer this letter within the given time frame.
That’s right, there is also the deadline for answering!
If possible, there should not be any further delays of weeks or even more. At this point it is advisable to make inquiries. Feel free to seek constructive discussions with the National Association of Statutory Health Insurance Funds or ask third parties who may have done this several times to give you a hand.
At any time during the application process, you have many options to influence the process positively or to hand over the entire process. In many cases this is a very economical decision, as time and possibly even avoidable testing costs or the like can be avoided. Usually there are several solutions to a problem and some solutions are not immediately apparent.
So, ask us! We’ve literally done this a thousand times.